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US4439357A
Expired / Lapsed
US
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Process for obtaining hepatitis-safe, sterile hemoglobin solutions free of pyrogens and stroma
Assignee: Biotest AG
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Filing: 1982-07-30
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Granted: 1984-03-27
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Expires: 2002-07-30
Abstract
Abstract A process for obtaining hepatitis-safe, sterile, pyrogen- and stroma-free hemoglobin solutions of low potassium content comprising stirring an erythrocyte concentrate with about 1 to 6-times its volume of an about 5 to 15% aqueous solution of a sugar, sugar alcohol or high-molecular-weight colloid, adjusting the pH of the resulting suspension to about 5 to 6.5 with an acid which is physiologically tolerable as salt, allowing the erythrocytes to settle, removing the supernatant from the sediments, adjusting the pH of the sediment to about 7 to 8, homogenizing the sediment, adjusting its hematocrit to about 55 to 60%, treating the mass with a dilute beta-propiolactone solution, hemolyzing the residual solids and forming a suspension thereof, contacting the suspension with a cation exchanger in H + form until the pH has decreased to about 5 to 5.5 thereby to precipitate the stroma, separating from the liquid the cation exchanger and precipitated stroma, and adjusting the pH to about 7.2 to 7.6.
Inventors
- 👤 Klaus Bonhard
- 👤 Bertram Eichentopf
- 👤 Norbert Kothe
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-30 17:44
CPC Classifications
C; C07; C07K; C07K14/00; C07K14/795; C07K14/805; A; A61; A61L; A61L2/00; A61L2/16; A61L2/18; A61K; A61K38/00; A61L2103/00; A61L2103/05; Y; Y10; Y10S; Y10S530/00; Y10S530/827; Y10S530/829
Claims Analysis
Total Claims: 8
Claim 1
Independent Claim
159 words
A process for obtaining hepatitis-safe, sterile, pyrogen- and stroma-free hemoglobin solutions of low potassium content comprising stirring an erythrocyte concentrate with about 1 to 6-times its volume of an about 5 to 15% aqueous solution of a sugar, sugar alcohol or high-molecular-weight colloid, adJusting the pH of the resulting suspension to about 5 to 6.5 with an acid which is physiologically tolerable as salt, allowing the erythrocytes to settle, removing the supernatant from the sediments, adjusting the pH of the sediment to about 7 to 8, homogenizing the sediment, adjusting its hematocrit to about 55 to 60%, treating the mass with a dilute beta-propiolactone solution, hemolyzing the residual solids and forming a suspension thereof, contacting the suspension with a cation exchanger in H + form until the pH has decreased to about 5 to 5.5 thereby to precipitate the stroma, separating from the liquid the cation exchanger and precipitated stroma, and adjusting the pH to about 7.2 to 7.6.
Claim 2
Dependent Claim
159 words
A process for obtaining hepatitis-safe, sterile, pyrogen- and stroma-free hemoglobin solutions of low potassium content comprising stirring an erythrocyte concentrate with about 1 to 6-times its volume of an about 5 to 15% aqueous solution of a sugar, sugar alcohol or high-molecular-weight colloid, adJusting the pH of the resulting suspension to about 5 to 6.5 with an acid which is physiologically tolerable as salt, allowing the erythrocytes to settle, removing the supernatant from the sediments, adjusting the pH of the sediment to about 7 to 8, homogenizing the sediment, adjusting its hematocrit to about 55 to 60%, treating the mass with a dilute beta-propiolactone solution, hemolyzing the residual solids and forming a suspension thereof, contacting the suspension with a cation exchanger in H + form until the pH has decreased to about 5 to 5.5 thereby to precipitate the stroma, separating from the liquid the cation exchanger and precipitated stroma, and adjusting the pH to about 7.2 to 7.6.
Claim 3
Dependent Claim
27 words
A process according to claim 1, wherein the temperature is from about 2° to 18° C. during the process up until at least the cation exchanger treatment.
Claim 4
Dependent Claim
24 words
A process according to claim 1, wherein the pH of the suspension is adjusted to about 5.4 prior to the settling of the erythrocytes.
Claim 5
Dependent Claim
21 words
A process according to claim 1, wherein the erythrocytes are allowed to settle for from about 15 minutes to 10 hours.
Claim 6
Dependent Claim
22 words
A process according to claim 1, wherein the pH of the sediment is adjusted to about 7.4 prior to the beta-propiolactone treatment.
Claim 7
Dependent Claim
53 words
A process according to claim 1, wherein one additional washing of the erythrocyte sediment with solution of sugar, sugar alcohol or colloid is performed before the beta-propiolactone treatment, and, after the beta-propiolactone treatment but before the cation exchanger treatment, the solids are washed three times with solution of sugar, sugar alcohol or colloid.
Claim 8
Dependent Claim
16 words
A process according to claim 6, including the further step of sterile filtering the final solution.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1987-03-27 | 1987-09-26 | 1988-03-27 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1991-03-27 | 1991-09-26 | 1992-03-27 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1995-03-27 | 1995-09-26 | 1996-03-27 | $7700.00 | Window Closed / Lapsed |